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1. Nuclear Physics Mid Term Plan at LNGS

Author

Buompane, R., Cavanna, F., Curceanu, C., D’Onofrio, A., Di Leva, A., Formicola, A., Gialanella, L., Gustavino, C., Imbriani, G., Junker, M., Marcianò, A., Marzaioli, F., Nania, R., Napolitano, F., Piscicchia, K., Straniero, O., Abia, C., Aliotta, M., Bemmerer, D., Best, A., Boeltzig, A., Bruno, C., Caciolli, A., Chieffi, A., Ciani, G., D’Agata, G., deBoer, R. J., De Cesare, M., Dell’Aquila, D., Depalo, R., Dominguez, I., Ferraro, F., Garcia Duarte, J., Guglielmetti, A., Gyürky, Gy., Hayakawa, S., La Cognata, M., Lamia, L., Marcucci, L. E., Masha, E., Mazzocco, M., Morales-Gallegos, E. L., Palmerini, S., Passariello, I., Petraglia, A., Piatti, D., Pignatari, M., Pizzone, R. G., Porzio, G., Rapagnani, D., Rapisarda, G. G., Romano, S., Rubino, M., Santonastaso, C., Sergi, M. L., Skowronski, J., Spartà, R., Terrasi, F., Tumino, A., Turkat, S., Wiescher, M., and Zavatarelli, S.

Published
2024
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4. Measurement of 1323 and 1487 keV resonances in 15N({\alpha}, {\gamma})19F with the recoil separator ERNA

Author

Di Leva, A., Imbriani, G., Buompane, R., Gialanella, L., Best, A., Cristallo, S., De Cesare, M., D'Onofrio, A., Duarte, J. G., Gasques, L. R., Morales-Gallegos, L., Pezzella, A., Porzio, G., Rapagnani, D., Roca, V., Romoli, M., Schürmann, D., Straniero, O., and Terrasi, F.

Subjects
Nuclear Experiment
Abstract

The origin of fluorine is a widely debated issue. Nevertheless, the ^{15}N({\alpha},{\gamma})^{19}F reaction is a common feature among the various production channels so far proposed. Its reaction rate at relevant temperatures is determined by a number of narrow resonances together with the DC component and the tails of the two broad resonances at E_{c.m.} = 1323 and 1487 keV. Measurement through the direct detection of the 19F recoil ions with the European Recoil separator for Nuclear Astrophysics (ERNA) were performed. The reaction was initiated by a 15N beam impinging onto a 4He windowless gas target. The observed yield of the resonances at Ec.m. = 1323 and 1487 keV is used to determine their widths in the {\alpha} and {\gamma} channels. We show that a direct measurement of the cross section of the ^{15}N({\alpha},{\gamma})^{19}F reaction can be successfully obtained with the Recoil Separator ERNA, and the widths {\Gamma}_{\gamma} and {\Gamma}_{\alpha} of the two broad resonances have been determined. While a fair agreement is found with earlier determination of the widths of the 1487 keV resonance, a significant difference is found for the 1323 keV resonance {\Gamma}_{\alpha} . The revision of the widths of the two more relevant broad resonances in the 15N({\alpha},{\gamma})19F reaction presented in this work is the first step toward a more firm determination of the reaction rate. At present, the residual uncertainty at the temperatures of the ^{19}F stellar nucleosynthesis is dominated by the uncertainties affecting the Direct Capture component and the 364 keV narrow resonance, both so far investigated only through indirect experiments., Comment: 8 pages, 11 figures. Accepted for publication in PRC

Published
2017
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5. The lung immuno-oncology prognostic score (LIPS-3): a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer

Author

Banna, G.L., Cortellini, A., Cortinovis, D.L., Tiseo, M., Aerts, J.G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., and Addeo, A.

Published
2021
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8. Direct measurements of the $$^{12}$$C+$$^{12}$$C reactions cross-sections towards astrophysical energies

Author

Morales-Gallegos, L., primary, Aliotta, M., additional, Gialanella, L., additional, Best, A., additional, Bruno, C. G., additional, Buompane, R., additional, Davinson, T., additional, De Cesare, M., additional, Di Leva, A., additional, D’Onofrio, A., additional, Duarte, J. G., additional, Gasques, L. R., additional, Imbriani, G., additional, Porzio, G., additional, Rapagnani, D., additional, Romoli, M., additional, and Terrasi, F., additional

Published
2024
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9. Osimertinib beyond disease progression in T790M EGFR-positive NSCLC patients: a multicenter study of clinicians’ attitudes

Author

Cortellini, A., Leonetti, A., Catino, A., Pizzutillo, P., Ricciuti, B., De Giglio, A., Chiari, R., Bordi, P., Santini, D., Giusti, R., De Tursi, M., Brocco, D., Zoratto, F., Rastelli, F., Citarella, F., Russano, M., Filetti, M., Marchetti, P., Berardi, R., Torniai, M., Cortinovis, D., Sala, E., Maggioni, C., Follador, A., Macerelli, M., Nigro, O., Tuzi, A., Iacono, D., Migliorino, M. R., Banna, G., Porzio, G., Cannita, K., Ferrara, M. G., Bria, E., Galetta, D., Ficorella, C., and Tiseo, M.

Published
2020
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12. Host immune-inflammatory markers to unravel the heterogeneous outcome and assessment of patients with PD-L1 ≥50% metastatic non-small cell lung cancer and poor performance status receiving first-line immunotherapy

Author

Banna, G, Tiseo, M, Cortinovis, D, Facchinetti, F, Aerts, J, Baldessari, C, Giusti, R, Bria, E, Grossi, F, Berardi, R, Morabito, A, Catino, A, Genova, C, Mazzoni, F, Gelibter, A, Rastelli, F, Macerelli, M, Chiari, R, Gori, S, Mansueto, G, Citarella, F, Cantini, L, Rijavec, E, Bertolini, F, Cappuzzo, F, De Toma, A, Friedlaender, A, Metro, G, Pensieri, M, Porzio, G, Ficorella, C, Pinato, D, Cortellini, A, Addeo, A, Banna GL, Tiseo M, Cortinovis D, Facchinetti F, Aerts JGJV, Baldessari C, Giusti R, Bria E, Grossi F, Berardi R, Morabito A, Catino A, Genova C, Mazzoni F, Gelibter A, Rastelli F, Macerelli M, Chiari R, Gori S, Mansueto G, Citarella F, Cantini L, Rijavec E, Bertolini F, Cappuzzo F, De Toma A, Friedlaender A, Metro G, Pensieri MV, Porzio G, Ficorella C, Pinato DJ, Cortellini A, Addeo A, Banna, G, Tiseo, M, Cortinovis, D, Facchinetti, F, Aerts, J, Baldessari, C, Giusti, R, Bria, E, Grossi, F, Berardi, R, Morabito, A, Catino, A, Genova, C, Mazzoni, F, Gelibter, A, Rastelli, F, Macerelli, M, Chiari, R, Gori, S, Mansueto, G, Citarella, F, Cantini, L, Rijavec, E, Bertolini, F, Cappuzzo, F, De Toma, A, Friedlaender, A, Metro, G, Pensieri, M, Porzio, G, Ficorella, C, Pinato, D, Cortellini, A, Addeo, A, Banna GL, Tiseo M, Cortinovis D, Facchinetti F, Aerts JGJV, Baldessari C, Giusti R, Bria E, Grossi F, Berardi R, Morabito A, Catino A, Genova C, Mazzoni F, Gelibter A, Rastelli F, Macerelli M, Chiari R, Gori S, Mansueto G, Citarella F, Cantini L, Rijavec E, Bertolini F, Cappuzzo F, De Toma A, Friedlaender A, Metro G, Pensieri MV, Porzio G, Ficorella C, Pinato DJ, Cortellini A, and Addeo A

Abstract

Background: Patients with programmed cell death-ligand 1 (PD-L1) ≥50% metastatic non-small cell lung cancer (mNSCLC) and ECOG performance status (PS) of 2 treated with first-line immunotherapy have heterogeneous clinical assessment and outcomes. Methods: To explore the role of immune-inflammatory surrogates by the validated lung immuno-oncology prognostic score (LIPS) score, including the neutrophil-to-lymphocyte ratio (NLR) and the pretreatment use of steroids, alongside other prognostic variables. A retrospective analysis of 128 patients with PS2 and PD-L1 ≥50% mNSCLC treated between April 2018 and September 2019 with first-line pembrolizumab in a real-world setting was performed. Results: With a median follow-up of 15.3 months, the 1-year overall survival (OS) and median progression-free survival (PFS) were 32.3% (95% CI: 30.9–33.9) and 3.3 months (95% CI: 1.8–4.7), respectively. The NLR, lactate dehydrogenase (LDH) and pretreatment steroids results were the only significant prognostic factors on the univariate analysis and independent prognostic factors by the multivariate analysis on both OS and PFS. The LIPS score, including the NLR and pretreatment steroids, identified 29 (23%) favourable-risk patients, with 0 factors, 1-year OS of 67.6% and median PFS of 8.2 months; 57 (45%) intermediate-risk patients, with 1 factor, 1-year OS 32.1% and median PFS 2.7 months; 42 (33%) poor-risk patients, with both factors, 1-year OS of 10.7% and median PFS of 1.2 months. Conclusions: The assessment of pre-existing imbalance of the host immune response by combined blood and clinical immune-inflammatory markers may represent a way to unravel the heterogeneous outcome and assessment of patients with mNSCLC and poor PS in the immune-oncology setting.

Published
2022

14. Corrigendum to “Ion beam analysis for recession determination and composition estimate of aerospace thermal protection system materials” [Nucl. Inst. Methods Phys. Res. B 467 (2020) 53–57]

Author

Rapagnani, D., primary, De Cesare, M., additional, Alfano, D., additional, Buompane, R., additional, Cantoni, S., additional, De Stefano Fumo, M., additional, Del Vecchio, A., additional, D'Onofrio, A., additional, Porzio, G., additional, Rufolo, G.C., additional, and Gialanella, L., additional

Published
2022
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16. Corrigendum to 'Ion beam analysis for recession determination and composition estimate of aerospace thermal protection system materials' [Nucl. Inst. Methods Phys. Res. B 467 (2020) 53–57, (S0168583X20300069), (10.1016/j.nimb.2020.01.006)]

Author

Rapagnani D., De Cesare M., Alfano D., Buompane R., Cantoni S., De Stefano Fumo M., Del Vecchio A., D'Onofrio A., Porzio G., Rufolo G. C., Gialanella L., Rapagnani, D., De Cesare, M., Alfano, D., Buompane, R., Cantoni, S., De Stefano Fumo, M., Del Vecchio, A., D'Onofrio, A., Porzio, G., Rufolo, G. C., and Gialanella, L.

Published
2022

17. Predictive ability of a drug-based score in patients with advanced non-small-cell lung cancer receiving first-line immunotherapy

Author

Buti, S, Bersanelli, M, Perrone, F, Bracarda, S, Di Maio, M, Giusti, R, Nigro, O, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Ferrara, M, Bria, E, Grossi, F, Bareggi, C, Berardi, R, Torniai, M, Cantini, L, Sforza, V, Genova, C, Chiari, R, Rocco, D, Della Gravara, L, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Citarella, F, Russano, M, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Follador, A, Bisonni, R, Tuzi, A, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Tabbò, F, Olmetto, E, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Addeo, A, Friedlaender, A, Cannita, K, Porzio, G, Ficorella, C, Carmisciano, L, Pinato, D, Mazzaschi, G, Tiseo, M, Cortellini, A, Buti S, Bersanelli M, Perrone F, Bracarda S, Di Maio M, Giusti R, Nigro O, Cortinovis D, Aerts JGJV, Guaitoli G, Barbieri F, Ferrara MG, Bria E, Grossi F, Bareggi C, Berardi R, Torniai M, Cantini L, Sforza V, Genova C, Chiari R, Rocco D, Della Gravara L, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Citarella F, Russano M, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Follador A, Bisonni R, Tuzi A, Minuti G, Landi L, Ricciardi S, Migliorino MR, Tabbò F, Olmetto E, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Addeo A, Friedlaender A, Cannita K, Porzio G, Ficorella C, Carmisciano L, Pinato DJ, Mazzaschi G, Tiseo M, Cortellini A, Buti, S, Bersanelli, M, Perrone, F, Bracarda, S, Di Maio, M, Giusti, R, Nigro, O, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Ferrara, M, Bria, E, Grossi, F, Bareggi, C, Berardi, R, Torniai, M, Cantini, L, Sforza, V, Genova, C, Chiari, R, Rocco, D, Della Gravara, L, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Citarella, F, Russano, M, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Follador, A, Bisonni, R, Tuzi, A, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Tabbò, F, Olmetto, E, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Addeo, A, Friedlaender, A, Cannita, K, Porzio, G, Ficorella, C, Carmisciano, L, Pinato, D, Mazzaschi, G, Tiseo, M, Cortellini, A, Buti S, Bersanelli M, Perrone F, Bracarda S, Di Maio M, Giusti R, Nigro O, Cortinovis D, Aerts JGJV, Guaitoli G, Barbieri F, Ferrara MG, Bria E, Grossi F, Bareggi C, Berardi R, Torniai M, Cantini L, Sforza V, Genova C, Chiari R, Rocco D, Della Gravara L, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Citarella F, Russano M, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Follador A, Bisonni R, Tuzi A, Minuti G, Landi L, Ricciardi S, Migliorino MR, Tabbò F, Olmetto E, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Addeo A, Friedlaender A, Cannita K, Porzio G, Ficorella C, Carmisciano L, Pinato DJ, Mazzaschi G, Tiseo M, and Cortellini A

Abstract

Background: We previously demonstrated the cumulative poor prognostic role of concomitant medications on the clinical outcome of patients with advanced cancer treated with immune checkpoint inhibitors, creating and validating a drug-based prognostic score to be calculated before immunotherapy initiation in patients with advanced solid tumours. This ‘drug score’ was calculated assigning score 1 for each between proton-pump inhibitor and antibiotic administration until a month before cancer therapy initiation and score 2 in case of corticosteroid intake. The good risk group included patients with score 0, intermediate risk with score 1–2 and poor risk with score 3–4. Methods: Aiming at validating the prognostic and putative predictive ability depending on the anticancer therapy, we performed the present comparative analysis in two cohorts of advanced non–small-cell lung cancer (NSCLC), respectively, receiving first-line pembrolizumab or chemotherapy through a random case-control matching and through a pooled multivariable analysis including the interaction between the computed score and the therapeutic modality (pembrolizumab vs chemotherapy). Results: Nine hundred fifty and 595 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. After the case-control random matching, 589 patients from the pembrolizumab cohort and 589 from the chemotherapy cohort were paired, with no statistically significant differences between the characteristics of the matched subjects. Among the pembrolizumab-treated group, good, intermediate and poor risk evaluable patients achieved an objective response rate (ORR) of 50.0%, 37.7% and 23.4%, respectively, (p < 0.0001), whereas among the chemotherapy-treated group, patients achieved an ORR of 37.0%, 40.0% and 32.4%, respectively (p = 0.4346). The median progression-free survival (PFS) of good, intermediate and poor risk groups was 13.9 months, 6.3 months and 2.8 months, respectively, within the pembrolizumab coh

Published
2021

18. Differential influence of antibiotic therapy and other medications on oncological outcomes of patients with non-small cell lung cancer treated with first-line pembrolizumab versus cytotoxic chemotherapy

Author

Cortellini, A, Di Maio, M, Nigro, O, Leonetti, A, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Giusti, R, Ferrara, M, Bria, E, D'Argento, E, Grossi, F, Rijavec, E, Guida, A, Berardi, R, Torniai, M, Sforza, V, Genova, C, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Della Gravara, L, Inno, A, Michele, T, Grassadonia, A, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Santini, D, Citarella, F, Russano, M, Cantini, L, Tuzi, A, Bordi, P, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Passiglia, F, Bironzo, P, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Friedlaender, A, Addeo, A, Cannita, K, Ficorella, C, Porzio, G, Pinato, D, Cortellini A, Di Maio M, Nigro O, Leonetti A, Cortinovis D, Aerts JG, Guaitoli G, Barbieri F, Giusti R, Ferrara MG, Bria E, D'Argento E, Grossi F, Rijavec E, Guida A, Berardi R, Torniai M, Sforza V, Genova C, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Della Gravara L, Inno A, Michele T, Grassadonia A, Di Marino P, Mansueto G, Zoratto F, Filetti M, Santini D, Citarella F, Russano M, Cantini L, Tuzi A, Bordi P, Minuti G, Landi L, Ricciardi S, Migliorino MR, Passiglia F, Bironzo P, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Friedlaender A, Addeo A, Cannita K, Ficorella C, Porzio G, Pinato DJ, Cortellini, A, Di Maio, M, Nigro, O, Leonetti, A, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Giusti, R, Ferrara, M, Bria, E, D'Argento, E, Grossi, F, Rijavec, E, Guida, A, Berardi, R, Torniai, M, Sforza, V, Genova, C, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Della Gravara, L, Inno, A, Michele, T, Grassadonia, A, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Santini, D, Citarella, F, Russano, M, Cantini, L, Tuzi, A, Bordi, P, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Passiglia, F, Bironzo, P, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Friedlaender, A, Addeo, A, Cannita, K, Ficorella, C, Porzio, G, Pinato, D, Cortellini A, Di Maio M, Nigro O, Leonetti A, Cortinovis D, Aerts JG, Guaitoli G, Barbieri F, Giusti R, Ferrara MG, Bria E, D'Argento E, Grossi F, Rijavec E, Guida A, Berardi R, Torniai M, Sforza V, Genova C, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Della Gravara L, Inno A, Michele T, Grassadonia A, Di Marino P, Mansueto G, Zoratto F, Filetti M, Santini D, Citarella F, Russano M, Cantini L, Tuzi A, Bordi P, Minuti G, Landi L, Ricciardi S, Migliorino MR, Passiglia F, Bironzo P, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Friedlaender A, Addeo A, Cannita K, Ficorella C, Porzio G, and Pinato DJ

Abstract

Background Some concomitant medications including antibiotics (ATB) have been reproducibly associated with worse survival following immune checkpoint inhibitors (ICIs) in unselected patients with non-small cell lung cancer (NSCLC) (according to programmed death-ligand 1 (PD-L1) expression and treatment line). Whether such relationship is causative or associative is matter of debate. Methods We present the outcomes analysis according to concomitant baseline medications (prior to ICI initiation) with putative immune-modulatory effects in a large cohort of patients with metastatic NSCLC with a PD-L1 expression >= 50%, receiving first-line pembrolizumab monotherapy. We also evaluated a control cohort of patients with metastatic NSCLC treated with first-line chemotherapy. The interaction between key medications and therapeutic modality (pembrolizumab vs chemotherapy) was validated in pooled multivariable analyses. Results 950 and 595 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. Corticosteroid and proton pump inhibitor (PPI) therapy but not ATB therapy was associated with poorer performance status at baseline in both the cohorts. No association with clinical outcomes was found according to baseline statin, aspirin, beta-blocker and metformin within the pembrolizumab cohort. On the multivariable analysis, ATB emerged as a strong predictor of worse overall survival (OS) (HR=1.42 (95% CI 1.13 to 1.79); p=0.0024), and progression free survival (PFS) (HR=1.29 (95% CI 1.04 to 1.59); p=0.0192) in the pembrolizumab but not in the chemotherapy cohort. Corticosteroids were associated with shorter PFS (HR=1.69 (95% CI 1.42 to 2.03); p<0.0001), and OS (HR=1.93 (95% CI 1.59 to 2.35); p<0.0001) following pembrolizumab, and shorter PFS (HR=1.30 (95% CI 1.08 to 1.56), p=0.0046) and OS (HR=1.58 (95% CI 1.29 to 1.94), p<0.0001), following chemotherapy. PPIs were associated with worse OS (HR=1.49 (95% CI 1.26 to 1.77); p<0.0001) with pem

Published
2021

19. Smoking status during first-line immunotherapy and chemotherapy in NSCLC patients: A case-control matched analysis from a large multicenter study

Author

Cortellini, A, De Giglio, A, Cannita, K, Cortinovis, D, Cornelissen, R, Baldessari, C, Giusti, R, D'Argento, E, Grossi, F, Santoni, M, Catino, A, Berardi, R, Sforza, V, Rossi, G, Antonuzzo, L, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Follador, A, Rastelli, F, Chiari, R, Gravara, L, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Pensieri, M, Russano, M, Cantini, L, Nigro, O, Leonetti, A, Bordi, P, Minuti, G, Landi, L, De Toma, A, Donisi, C, Ricciardi, S, Migliorino, M, Napoli, V, Leone, G, Metro, G, Banna, G, Friedlaender, A, Addeo, A, Ficorella, C, Porzio, G, Cortellini A, De Giglio A, Cannita K, Cortinovis D, Cornelissen R, Baldessari C, Giusti R, D'Argento E, Grossi F, Santoni M, Catino A, Berardi R, Sforza V, Rossi G, Antonuzzo L, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Follador A, Rastelli F, Chiari R, Gravara LD, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Pensieri MV, Russano M, Cantini L, Nigro O, Leonetti A, Bordi P, Minuti G, Landi L, De Toma A, Donisi C, Ricciardi S, Migliorino MR, Napoli VM, Leone G, Metro G, Banna GL, Friedlaender A, Addeo A, Ficorella C, Porzio G, Cortellini, A, De Giglio, A, Cannita, K, Cortinovis, D, Cornelissen, R, Baldessari, C, Giusti, R, D'Argento, E, Grossi, F, Santoni, M, Catino, A, Berardi, R, Sforza, V, Rossi, G, Antonuzzo, L, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Follador, A, Rastelli, F, Chiari, R, Gravara, L, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Pensieri, M, Russano, M, Cantini, L, Nigro, O, Leonetti, A, Bordi, P, Minuti, G, Landi, L, De Toma, A, Donisi, C, Ricciardi, S, Migliorino, M, Napoli, V, Leone, G, Metro, G, Banna, G, Friedlaender, A, Addeo, A, Ficorella, C, Porzio, G, Cortellini A, De Giglio A, Cannita K, Cortinovis D, Cornelissen R, Baldessari C, Giusti R, D'Argento E, Grossi F, Santoni M, Catino A, Berardi R, Sforza V, Rossi G, Antonuzzo L, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Follador A, Rastelli F, Chiari R, Gravara LD, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Pensieri MV, Russano M, Cantini L, Nigro O, Leonetti A, Bordi P, Minuti G, Landi L, De Toma A, Donisi C, Ricciardi S, Migliorino MR, Napoli VM, Leone G, Metro G, Banna GL, Friedlaender A, Addeo A, Ficorella C, and Porzio G

Abstract

Background: Improved outcome in tobacco smoking patients with non-small cell lung cancer (NSCLC) following immunotherapy has previously been reported. However, little is known regarding this association during first-line immunotherapy in patients with high PD-L1 expression. In this study we compared clinical outcomes according to the smoking status of two large multicenter cohorts. Methods: We compared clinical outcomes according to the smoking status (never smokers vs. current/former smokers) of two retrospective multicenter cohorts of metastatic NSCLC patients, treated with first-line pembrolizumab and platinum-based chemotherapy. Results: A total of 962 NSCLC patients with PD-L1 expression ≥50% who received first-line pembrolizumab and 462 NSCLC patients who received first-line platinum-based chemotherapy were included in the study. Never smokers were confirmed to have a significantly higher risk of disease progression (hazard ratio [HR] = 1.49 [95% CI: 1.15–1.92], p = 0.0022) and death (HR = 1.38 [95% CI: 1.02–1.87], p = 0.0348) within the pembrolizumab cohort. On the contrary, a nonsignificant trend towards a reduced risk of disease progression (HR = 0.74 [95% CI: 0.52–1.05], p = 0.1003) and death (HR = 0.67 [95% CI: 0.45–1.01], p = 0.0593) were reported for never smokers within the chemotherapy cohort. After a random case–control matching, 424 patients from both cohorts were paired. Within the matched pembrolizumab cohort, never smokers had a significantly shorter progression-free survival (PFS) (HR = 1.68 [95% CI: 1.17–2.40], p = 0.0045) and a nonsignificant trend towards a shortened overall survival (OS) (HR = 1.32 [95% CI: 0.84–2.07], p = 0.2205). On the contrary, never smokers had a significantly longer PFS (HR = 0.68 [95% CI: 0.49–0.95], p = 0.0255) and OS (HR = 0.66 [95% CI: 0.45–0.97], p = 0,0356) compared to current/former smoker patients within the matched chemotherapy cohort. On pooled multivariable analysis, the interaction term between smoking stat

Published
2021

20. The lung immuno-oncology prognostic score (LIPS-3): a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer

Author

Banna, G, Cortellini, A, Cortinovis, D, Tiseo, M, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Grossi, F, Pizzutilo, P, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Marco, R, Cantini, L, Nigro, O, D'Argento, E, Buti, S, Minuti, G, Landi, L, Guaitoli, G, Lo Russo, G, De Toma, A, Donisi, C, Friedlaender, A, De Giglio, A, Metro, G, Porzio, G, Ficorella, C, Addeo, A, Banna GL, Cortellini A, Cortinovis D, Tiseo M, Aerts JGJV, Barbieri F, Giusti R, Bria E, Grossi F, Pizzutilo P, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Marco R, Cantini L, Nigro O, D'Argento E, Buti S, Minuti G, Landi L, Guaitoli G, Lo Russo G, De Toma A, Donisi C, Friedlaender A, De Giglio A, Metro G, Porzio G, Ficorella C, Addeo A., Banna, G, Cortellini, A, Cortinovis, D, Tiseo, M, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Grossi, F, Pizzutilo, P, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Marco, R, Cantini, L, Nigro, O, D'Argento, E, Buti, S, Minuti, G, Landi, L, Guaitoli, G, Lo Russo, G, De Toma, A, Donisi, C, Friedlaender, A, De Giglio, A, Metro, G, Porzio, G, Ficorella, C, Addeo, A, Banna GL, Cortellini A, Cortinovis D, Tiseo M, Aerts JGJV, Barbieri F, Giusti R, Bria E, Grossi F, Pizzutilo P, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Marco R, Cantini L, Nigro O, D'Argento E, Buti S, Minuti G, Landi L, Guaitoli G, Lo Russo G, De Toma A, Donisi C, Friedlaender A, De Giglio A, Metro G, Porzio G, Ficorella C, and Addeo A.

Abstract

Background: To stratify the prognosis of patients with programmed cell death-ligand 1 (PD-L1) ≥ 50% advanced non-small-cell lung cancer (aNSCLC) treated with first-line immunotherapy. Methods: Baseline clinical prognostic factors, the neutrophil-to-lymphocyte ratio (NLR), PD-L1 tumour cell expression level, lactate dehydrogenase (LDH) and their combination were investigated by a retrospective analysis of 784 patients divided between statistically powered training (n = 201) and validation (n = 583) cohorts. Cut-offs were explored by receiver operating characteristic (ROC) curves and a risk model built with validated independent factors by multivariate analysis. Results: NLR < 4 was a significant prognostic factor in both cohorts (P < 0.001). It represented 53% of patients in the validation cohort, with 1-year overall survival (OS) of 76.6% versus 44.8% with NLR > 4, in the validation series. The addition of PD-L1 ≥ 80% (21% of patients) or LDH < 252 U/l (25%) to NLR < 4 did not result in better 1-year OS (of 72.6% and 74.1%, respectively, in the validation cohort). Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 [P < 0.001, hazard ratio (HR) 2.04], pretreatment steroids (P < 0.001, HR 1.67) and NLR < 4 (P < 0.001, HR 2.29) resulted in independent prognostic factors. A risk model with these three factors, namely, the lung immuno-oncology prognostic score (LIPS)-3, accurately stratified three OS risk-validated categories of patients: favourable (0 risk factors, 40%, 1-year OS of 78.2% in the whole series), intermediate (1 or 2 risk factors, 54%, 1-year OS 53.8%) and poor (>2 risk factors, 5%, 1-year OS 10.7%) prognosis. Conclusions: We advocate the use of LIPS-3 as an easy-to-assess and inexpensive adjuvant prognostic tool for patients with PD-L1 ≥ 50% aNSCLC.

Published
2021

21. Post-progression outcomes of NSCLC patients with PD-L1 expression ≥ 50% receiving first-line single-agent pembrolizumab in a large multicentre real-world study

Author

Cortellini, A, Cannita, K, Tiseo, M, Cortinovis, D, Aerts, J, Baldessari, C, Giusti, R, Ferrara, M, D'Argento, E, Grossi, F, Guida, A, Berardi, R, Morabito, A, Genova, C, Antonuzzo, L, Mazzoni, F, De Toma, A, Signorelli, D, Gelibter, A, Targato, G, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Filetti, M, Bracarda, S, Citarella, F, Russano, M, Cantini, L, Nigro, O, Buti, S, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Natalizio, S, Simona, C, De Filippis, M, Metro, G, Adamo, V, Russo, A, Spinelli, G, Di Maio, M, Banna, G, Friedlaender, A, Addeo, A, Pinato, D, Ficorella, C, Porzio, G, Cortellini A, Cannita K, Tiseo M, Cortinovis D, Aerts JGJV, Baldessari C, Giusti R, Ferrara MG, D'Argento E, Grossi F, Guida A, Berardi R, Morabito A, Genova C, Antonuzzo L, Mazzoni F, De Toma A, Signorelli D, Gelibter A, Targato G, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Filetti M, Bracarda S, Citarella F, Russano M, Cantini L, Nigro O, Buti S, Minuti G, Landi L, Ricciardi S, Migliorino MR, Natalizio S, Simona C, De Filippis M, Metro G, Adamo V, Russo A, Spinelli GP, Di Maio M, Banna GL, Friedlaender A, Addeo A, Pinato DJ, Ficorella C, Porzio G, Cortellini, A, Cannita, K, Tiseo, M, Cortinovis, D, Aerts, J, Baldessari, C, Giusti, R, Ferrara, M, D'Argento, E, Grossi, F, Guida, A, Berardi, R, Morabito, A, Genova, C, Antonuzzo, L, Mazzoni, F, De Toma, A, Signorelli, D, Gelibter, A, Targato, G, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Filetti, M, Bracarda, S, Citarella, F, Russano, M, Cantini, L, Nigro, O, Buti, S, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Natalizio, S, Simona, C, De Filippis, M, Metro, G, Adamo, V, Russo, A, Spinelli, G, Di Maio, M, Banna, G, Friedlaender, A, Addeo, A, Pinato, D, Ficorella, C, Porzio, G, Cortellini A, Cannita K, Tiseo M, Cortinovis D, Aerts JGJV, Baldessari C, Giusti R, Ferrara MG, D'Argento E, Grossi F, Guida A, Berardi R, Morabito A, Genova C, Antonuzzo L, Mazzoni F, De Toma A, Signorelli D, Gelibter A, Targato G, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Filetti M, Bracarda S, Citarella F, Russano M, Cantini L, Nigro O, Buti S, Minuti G, Landi L, Ricciardi S, Migliorino MR, Natalizio S, Simona C, De Filippis M, Metro G, Adamo V, Russo A, Spinelli GP, Di Maio M, Banna GL, Friedlaender A, Addeo A, Pinato DJ, Ficorella C, and Porzio G

Abstract

Background: Treatment sequencing with first-line immunotherapy, followed by second-line chemotherapy, is still a viable option for NSCLC patients with PD-L1 expression ≥50%. Methods: We evaluated post-progression treatment pathways in a large real-world cohort of metastatic NSCLC patients with PD-L1 expression ≥ 50% treated with first-line pembrolizumab monotherapy. Results: Overall, 974 patients were included. With a median follow-up of 22.7 months (95%CI: 21.6–38.2), the median overall survival (OS) of the entire population was 15.8 months (95%CI: 13.5–17.5; 548 events). At the data cutoff, among the 678 patients who experienced disease progression, 379 (55.9%) had not received any further treatment, and 359 patients (52.9%) had died. Patients who did not receive post-progression therapies were older (p = 0.0011), with a worse ECOG-PS (p < 0.0001) and were on corticosteroids prior to pembrolizumab (p = 0.0024). At disease progression, 198 patients (29.2%) received a switched approach and 101 (14.9%) received pembrolizumab ByPD either alone (64 [9.4%]) or in combination with local ablative treatments (37 [5.5%]) (LATs). After a random-case control matching according to ECOG-PS, CNS metastases, bone metastases, and (previous) best response to pembrolizumab, patients receiving pembrolizumab ByPD plus LATs were confirmed to have a significantly longer post-progression OS compared to patients receiving pembrolizumab ByPD alone 13.9 months versus 7.8 months (p = 0.0179) 241 patients (35.5%) among the 678 who had experienced PD, received a second-line systemic treatment (regardless of previous treatment beyond PD). As compared to first-line treatment commencement, patients’ features at the moment of second-line initiation showed a significantly higher proportion of patients aged under 70 years (p = 0.0244), with a poorer ECOG-PS (p < 0.0001) and having CNS (p = 0.0001), bone (p = 0.0266) and liver metastases (p = 0.0148). Conclusions: In the real-world scenario NSC

Published
2021

25. Test measurement of 7Be(p,γ)8B with the recoil mass separator ERNA

Author

Buompane, R., De Cesare, N., Di Leva, A., D’Onofrio, A., Gialanella, L., Romano, M., De Cesare, M., Duarte, J. G., Fülöp, Zs., Morales-Gallegos, L., Gyürky, Gy., Gasques, L. R., Marzaioli, F., Palumbo, G., Porzio, G., Rapagnani, D., Roca, V., Rogalla, D., Romoli, M., Sabbarese, C., Schürmann, D., and Terrasi, F.

Published
2018
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26. Validation of a novel technique with radioactive implanted ions for recession rate estimate of aerospace material

Author

Rapagnani, D, De Cesare, M, Buompane, R, Del Vecchio, A, Di Leva, A, D'Onofrio, A, Porzio, G, Gialanella, L, Rapagnani, D., De Cesare, M., Buompane, R., Del Vecchio, A., Di Leva, A., D'Onofrio, A., Porzio, G., Gialanella, L., Rapagnani, D, De Cesare, M, Buompane, R, Del Vecchio, A, Di Leva, A, D'Onofrio, A, Porzio, G, and Gialanella, L

Subjects
radioactive ion, thermal protection system, plasma wind tunnel, nuclear physics, remote sensor, gamma irradiation, reentry physics methodology
Abstract

Durability tests of thermal protection system (TPS) materials for space vehicles is of paramount importance in developing TPS materials. The limits of the presently used techniques and the need for higher accuracy and precision demand new reliable and more sensitive measurement methods. In this paper we present the validation of a new on-line and non intrusive technique to estimate the TPS material recession rate which exploits the surface layer implantation of radioactive Be-7 ions and the measurement of its characteristic gamma-rays during the recession test.

Published
2021

27. Osimertinib beyond disease progression in T790M EGFR-positive NSCLC patients: a multicenter study of clinicians' attitudes

Author

Cortellini, A, Leonetti, A, Catino, A, Pizzutillo, P, Ricciuti, B, De Giglio, A, Chiari, R, Bordi, P, Santini, D, Giusti, R, De Tursi, M, Brocco, D, Zoratto, F, Rastelli, F, Citarella, F, Russano, M, Filetti, M, Marchetti, P, Berardi, R, Torniai, M, Cortinovis, D, Sala, E, Maggioni, C, Follador, A, Macerelli, M, Nigro, O, Tuzi, A, Iacono, D, Migliorino, M, Banna, G, Porzio, G, Cannita, K, Ferrara, M, Bria, E, Galetta, D, Ficorella, C, Tiseo, M, Cortellini A, Leonetti A, Catino A, Pizzutillo P, Ricciuti B, De Giglio A, Chiari R, Bordi P, Santini D, Giusti R, De Tursi M, Brocco D, Zoratto F, Rastelli F, Citarella F, Russano M, Filetti M, Marchetti P, Berardi R, Torniai M, Cortinovis D, Sala E, Maggioni C, Follador A, Macerelli M, Nigro O, Tuzi A, Iacono D, Migliorino MR, Banna G, Porzio G, Cannita K, Ferrara MG, Bria E, Galetta D, Ficorella C, Tiseo M., Cortellini, A, Leonetti, A, Catino, A, Pizzutillo, P, Ricciuti, B, De Giglio, A, Chiari, R, Bordi, P, Santini, D, Giusti, R, De Tursi, M, Brocco, D, Zoratto, F, Rastelli, F, Citarella, F, Russano, M, Filetti, M, Marchetti, P, Berardi, R, Torniai, M, Cortinovis, D, Sala, E, Maggioni, C, Follador, A, Macerelli, M, Nigro, O, Tuzi, A, Iacono, D, Migliorino, M, Banna, G, Porzio, G, Cannita, K, Ferrara, M, Bria, E, Galetta, D, Ficorella, C, Tiseo, M, Cortellini A, Leonetti A, Catino A, Pizzutillo P, Ricciuti B, De Giglio A, Chiari R, Bordi P, Santini D, Giusti R, De Tursi M, Brocco D, Zoratto F, Rastelli F, Citarella F, Russano M, Filetti M, Marchetti P, Berardi R, Torniai M, Cortinovis D, Sala E, Maggioni C, Follador A, Macerelli M, Nigro O, Tuzi A, Iacono D, Migliorino MR, Banna G, Porzio G, Cannita K, Ferrara MG, Bria E, Galetta D, Ficorella C, and Tiseo M.

Abstract

Background: In most cases, T790M EGFR-positive NSCLC patients receiving osimertinib developed “non-drugable” progression, as the patients with common EGFR-sensitizing mutations were treated with first-line osimertinib. In both settings, chemotherapy represents the standard treatment and local ablative treatments (LATs) are potential useful options in the case of oligo-progression. Methods: We conducted a study on “post-progression” (pp) outcomes of T790M EGFR-positive NSCLC patients treated with osimertinib, according to the therapeutic strategy applied: osimertinib beyond progression (± LATs), “switched therapies” or best supportive care only (BSC). Results: 144 consecutive patients were evaluated: 53 (36.8%) did not received post-progression treatments (BSC), while 91 (63.2%) patients received at least 1 subsequent treatment; 50 patients (54.9%) received osimertinib beyond disease progression [19 (20.9%) of them with adjunctive LATs] and 41 (45.1%) a switched therapy. Median ppPFS (progression-free survival) and median ppOS (overall survival) of patients who received osimertinib beyond progression vs. switched therapies were 6.4 months vs. 4.7 months, respectively [HR 0.57 (95% CI 0.35–0.92), p = 0.0239] and 11.3 months vs 7.8 months, respectively [HR 0.57 (95% CI 0.33–0.98), p = 0.0446]. Among patients who received osimertinib beyond progression with and without LATs median ppPFS was 6.4 months and 5.7 months, respectively [HR 0.90 (95% CI 0.68–1.18), p = 0.4560], while median ppOS was 20.2 months and 9.9 months, respectively [HR 0.73 (95% CI 0.52–1.03), p = 0.0748]. At the univariate analysis, the only factor significantly related to the ppPFS was the therapeutic strategy in favor of osimertinib beyond progression (± LATs). Moreover, the only variable which was significantly related to ppOS at the multivariate analysis was osimertinib beyond progression (± LATs). Conclusion: Our study confirmed that in clinical practice, in case of “non-druggable” disease progre

Published
2020

28. Immune-related Adverse Events of Pembrolizumab in a Large Real-world Cohort of Patients With NSCLC With a PD-L1 Expression ≥ 50% and Their Relationship With Clinical Outcomes

Author

Cortellini, A, Friedlaender, A, Banna, G, Porzio, G, Bersanelli, M, Cappuzzo, F, Aerts, J, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Berardi, R, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, Di Marino, P, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Ghidini, M, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Occhipinti, M, Citarella, F, Marco, R, Torniai, M, Cantini, L, Follador, A, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Leonetti, A, Pettoruti, L, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Bertolini, F, Della Gravara, L, Dal Bello, M, Belderbos, R, De Filippis, M, Cecchi, C, Ricciardi, S, Donisi, C, De Toma, A, Proto, C, Addeo, A, Cantale, O, Ricciuti, B, Genova, C, Morabito, A, Santini, D, Ficorella, C, Cannita, K, Cortellini A, Friedlaender A, Banna GL, Porzio G, Bersanelli M, Cappuzzo F, Aerts JGJV, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Berardi R, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Inno A, Di Marino P, Mansueto G, Zoratto F, Santoni M, Tudini M, Ghidini M, Filetti M, Catino A, Pizzutilo P, Sala L, Occhipinti MA, Citarella F, Marco R, Torniai M, Cantini L, Follador A, Sforza V, Nigro O, Ferrara MG, D'Argento E, Leonetti A, Pettoruti L, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Bertolini F, Della Gravara L, Dal Bello MG, Belderbos RA, De Filippis M, Cecchi C, Ricciardi S, Donisi C, De Toma A, Proto C, Addeo A, Cantale O, Ricciuti B, Genova C, Morabito A, Santini D, Ficorella C, Cannita K., Cortellini, A, Friedlaender, A, Banna, G, Porzio, G, Bersanelli, M, Cappuzzo, F, Aerts, J, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Berardi, R, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, Di Marino, P, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Ghidini, M, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Occhipinti, M, Citarella, F, Marco, R, Torniai, M, Cantini, L, Follador, A, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Leonetti, A, Pettoruti, L, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Bertolini, F, Della Gravara, L, Dal Bello, M, Belderbos, R, De Filippis, M, Cecchi, C, Ricciardi, S, Donisi, C, De Toma, A, Proto, C, Addeo, A, Cantale, O, Ricciuti, B, Genova, C, Morabito, A, Santini, D, Ficorella, C, Cannita, K, Cortellini A, Friedlaender A, Banna GL, Porzio G, Bersanelli M, Cappuzzo F, Aerts JGJV, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Berardi R, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Inno A, Di Marino P, Mansueto G, Zoratto F, Santoni M, Tudini M, Ghidini M, Filetti M, Catino A, Pizzutilo P, Sala L, Occhipinti MA, Citarella F, Marco R, Torniai M, Cantini L, Follador A, Sforza V, Nigro O, Ferrara MG, D'Argento E, Leonetti A, Pettoruti L, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Bertolini F, Della Gravara L, Dal Bello MG, Belderbos RA, De Filippis M, Cecchi C, Ricciardi S, Donisi C, De Toma A, Proto C, Addeo A, Cantale O, Ricciuti B, Genova C, Morabito A, Santini D, Ficorella C, and Cannita K.

Abstract

Background: The role of immune-related adverse events (irAEs), as a surrogate predictor of the efficacy of checkpoint inhibitors, has not yet been described in the setting of first-line, single-agent pembrolizumab for patients with metastatic non-small-cell lung-cancer (NSCLC) with a programmed death-ligand 1 (PD-L1) expression of ≥ 50%. Patients and methods: We previously conducted a multicenter retrospective analysis in patients with treatment-naive metastatic NSCLC and a PD-L1 expression of ≥ 50% receiving first-line pembrolizumab. Here, we report the results of the irAE analysis and the potential correlation between irAEs and clinical outcomes. Results: A total of 1010 patients were included in this analysis; after a 6-week landmark selection, 877 (86.8%) patients were included in the efficacy analysis. Any grade irAEs (P < .0001), grade 3/4 irAEs (P = .0025), leading to discontinuation irAEs (P = .0144), multiple-site and single-site irAEs (P < .0001), cutaneous irAEs (P = .0001), endocrine irAEs (P = .0227), pulmonary irAEs (P = .0479), and rheumatologic irAEs (P = .0018) were significantly related to a higher objective response rate. Any grade irAEs (P < .0001), single-site irAEs (P < .0001), multiple-site irAEs (P = .0005), cutaneous irAEs (P = .0042), endocrine irAEs (P < .0001), gastrointestinal irAEs (P = .0391), and rheumatologic irAEs (P = .0086) were significantly related to progression-free survival. Any grade irAEs (P < .0001), single-site irAEs (P < .0001), multiple-site irAEs (P = .0003), cutaneous irAEs (P = .0002), endocrine irAEs (P = .0001), and rheumatologic irAEs (P = .0214) were significantly related to overall survival. Conclusions: This study confirms the feasibility and the safety of first-line, single-agent pembrolizumab, in a large, real-world cohort of patients with NSCLC with PD-L1 expression ≥ 50%. The occurrence of irAEs may be a surrogate of clinical activity and improved outcomes in this setting.

Published
2020

29. Baseline BMI and BMI variation during first line pembrolizumab in NSCLC patients with a PD-L1 expression ≥ 50%: a multicenter study with external validation

Author

Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, G, Aerts, J, Barbieri, F, Giusti, R, Cortinovis, D, Migliorino, M, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, L, Targato, G, Nigro, O, Ferrara, M, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbò, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, Ficorella, C, Cortellini A, Ricciuti B, Tiseo M, Bria E, Banna GL, Aerts JG, Barbieri F, Giusti R, Cortinovis D, Migliorino MR, Catino A, Passiglia F, Torniai M, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Rastelli F, Chiari R, Rocco D, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Grossi F, Filetti M, Pizzutilo P, Russano M, Citarella F, Cantini L, Targato G, Nigro O, Ferrara MG, Buti S, Scodes S, Landi L, Guaitoli G, Della Gravara L, Tabbò F, Ricciardi S, De Toma A, Friedlaender A, Petrelli F, Addeo A, Porzio G, Ficorella C., Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, G, Aerts, J, Barbieri, F, Giusti, R, Cortinovis, D, Migliorino, M, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, L, Targato, G, Nigro, O, Ferrara, M, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbò, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, Ficorella, C, Cortellini A, Ricciuti B, Tiseo M, Bria E, Banna GL, Aerts JG, Barbieri F, Giusti R, Cortinovis D, Migliorino MR, Catino A, Passiglia F, Torniai M, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Rastelli F, Chiari R, Rocco D, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Grossi F, Filetti M, Pizzutilo P, Russano M, Citarella F, Cantini L, Targato G, Nigro O, Ferrara MG, Buti S, Scodes S, Landi L, Guaitoli G, Della Gravara L, Tabbò F, Ricciardi S, De Toma A, Friedlaender A, Petrelli F, Addeo A, Porzio G, and Ficorella C.

Abstract

Background The association between obesity and outcomes in patients receiving programmed death-1/programmed death ligand-1 (PD-L1) checkpoint inhibitors has already been confirmed in pre-treated non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 tumor expression. Methods We present the outcomes analysis according to baseline body mass index (BMI) and BMI variation in a large cohort of metastatic NSCLC patients with a PD-L1 expression ≥50%, receiving first line pembrolizumab. We also evaluated a control cohort of metastatic NSCLC patients treated with first line platinum-based chemotherapy. Normal weight was set as control group. Results 962 patients and 426 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. Obese patients had a significantly higher objective response rate (ORR) (OR=1.61 (95% CI: 1.04-2.50)) in the pembrolizumab cohort, while overweight patients had a significantly lower ORR (OR=0.59 (95% CI: 0.37-0.92)) within the chemotherapy cohort. Obese patients had a significantly longer progression-free survival (PFS) (HR=0.61 (95% CI: 0.45-0.82)) in the pembrolizumab cohort. Conversely, they had a significantly shorter PFS in the chemotherapy cohort (HR=1.27 (95% CI: 1.01-1.60)). Obese patients had a significantly longer overall survival (OS) within the pembrolizumab cohort (HR=0.70 (95% CI: 0.49-0.99)), while no significant differences according to baseline BMI were found in the chemotherapy cohort. BMI variation significantly affected ORR, PFS and OS in both the pembrolizumab and the chemotherapy cohorts. Conclusions Baseline obesity is associated to significantly improved ORR, PFS and OS in metastatic NSCLC patients with a PD-L1 expression of ≥50%, receiving first line pembrolizumab, but not among patients treated with chemotherapy. BMI variation is also significantly related to clinical outcomes.

Published
2020

30. Clinicopathologic correlates of first-line pembrolizumab effectiveness in patients with advanced NSCLC and a PD-L1 expression of ≥ 50

Author

Cortellini, A, Tiseo, M, Banna, G, Cappuzzo, F, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Santini, D, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Rijavec, E, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Citarella, F, Marco, R, Torniai, M, Cantini, L, Targato, G, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Buti, S, Bordi, P, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Della Gravara, L, Dal Bello, M, Belderbos, R, Bironzo, P, Carnio, S, Ricciardi, S, Grieco, A, De Toma, A, Proto, C, Friedlaender, A, Cantale, O, Ricciuti, B, Addeo, A, Metro, G, Ficorella, C, Porzio, G, Cortellini A, Tiseo M, Banna GL, Cappuzzo F, Aerts JGJV, Barbieri F, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Santini D, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Santoni M, Tudini M, Rijavec E, Filetti M, Catino A, Pizzutilo P, Sala L, Citarella F, Marco R, Torniai M, Cantini L, Targato G, Sforza V, Nigro O, Ferrara MG, D'Argento E, Buti S, Bordi P, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Della Gravara L, Dal Bello MG, Belderbos RA, Bironzo P, Carnio S, Ricciardi S, Grieco A, De Toma A, Proto C, Friedlaender A, Cantale O, Ricciuti B, Addeo A, Metro G, Ficorella C, Porzio G., Cortellini, A, Tiseo, M, Banna, G, Cappuzzo, F, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Santini, D, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Rijavec, E, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Citarella, F, Marco, R, Torniai, M, Cantini, L, Targato, G, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Buti, S, Bordi, P, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Della Gravara, L, Dal Bello, M, Belderbos, R, Bironzo, P, Carnio, S, Ricciardi, S, Grieco, A, De Toma, A, Proto, C, Friedlaender, A, Cantale, O, Ricciuti, B, Addeo, A, Metro, G, Ficorella, C, Porzio, G, Cortellini A, Tiseo M, Banna GL, Cappuzzo F, Aerts JGJV, Barbieri F, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Santini D, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Santoni M, Tudini M, Rijavec E, Filetti M, Catino A, Pizzutilo P, Sala L, Citarella F, Marco R, Torniai M, Cantini L, Targato G, Sforza V, Nigro O, Ferrara MG, D'Argento E, Buti S, Bordi P, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Della Gravara L, Dal Bello MG, Belderbos RA, Bironzo P, Carnio S, Ricciardi S, Grieco A, De Toma A, Proto C, Friedlaender A, Cantale O, Ricciuti B, Addeo A, Metro G, Ficorella C, and Porzio G.

Abstract

Background: Single-agent pembrolizumab represents the standard first-line option for metastatic non-small-cell lung cancer (NSCLC) patients with a PD-L1 (programmed death-ligand 1) expression of ≥ 50%. Methods: We conducted a multicenter retrospective study aimed at evaluating the clinicopathologic correlates of pembrolizumab effectiveness in patients with treatment-naïve NSCLC and a PD-L1 expression of ≥ 50%. Results: One thousand and twenty-six consecutive patients were included. The objective response rate (ORR) was 44.5% (95% CI 40.2–49.1), while the median progression free survival (PFS) and overall survival (OS) were 7.9 months (95% CI 6.9–9.5; 599 events) and 17.2 months (95% CI 15.3–22.3; 598 censored patients), respectively. ECOG-PS ≥ 2 (p < 0.0001) and bone metastases (p = 0.0003) were confirmed to be independent predictors of a worse ORR. Former smokers (p = 0.0002), but not current smokers (p = 0.0532) were confirmed to have a significantly prolonged PFS compared to never smokers at multivariate analysis. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a worse PFS. Previous palliative RT was significantly related to a shortened OS (p = 0.0104), while previous non-palliative RT was significantly related to a prolonged OS (p = 0.0033). Former smokers (p = 0.0131), but not current smokers (p = 0.3433) were confirmed to have a significantly prolonged OS compared to never smokers. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a shortened OS. A PD-L1 expression of ≥ 90%, as assessed by recursive partitioning, was associated with significantly higher ORR (p = 0.0204), and longer and OS (p = 0.0346) at multivariable analysis. Conclusion: Pembrolizumab was effective in a large cohort of NSCLC patients treated outside of clinical trials. Questions regarding the effe

Published
2020

31. Direct measurements of the $$^{12}$$C+$$^{12}$$C reactions cross-sections towards astrophysical energies

Author

Morales-Gallegos, L., primary, Aliotta, M., additional, Gialanella, L., additional, Best, A., additional, Bruno, C. G., additional, Buompane, R., additional, Davinson, T., additional, De Cesare, M., additional, Di Leva, A., additional, D’Onofrio, A., additional, Duarte, J. G., additional, Gasques, L. R., additional, Imbriani, G., additional, Porzio, G., additional, Rapagnani, D., additional, Romoli, M., additional, and Terrasi, F., additional

Published
2022
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32. Artemisia a Napoli. Novità, problemi, prospettive

Author

Porzio, G.

Subjects
Artemisia Gentileschi, Viceregno, Napoli, collezionismo, naturalismo, pittura napoletana, Barocco, Napoli, Barocco, naturalismo, Artemisia Gentileschi, pittura napoletana, collezionismo, Viceregno
Published
2022

34. Determination of the Cross Section at Astrophysical Energies Using a Radioactive Be ion beam

Author

Buompane, R., Di Leva, A., Gialanella, L., D'Onofrio, A., De Cesare, M., Duarte, J.G., Fülöp, Z., Gasques, L.R., Gyürky, Gy., Morales-Gallegos, L., Marzaioli, F., Palumbo, G., Porzio, G., Rapagnani, D., Roca, V., Rogalla, D., Romoli, M., Santonastaso, C., and Schürmann, D.

Abstract

The reaction Be(p7,γ)8B plays an important role in the Sun, where it determines the high energy component of the solar neutrino spectrum. The importance of this reaction triggered several experiments over the last decades. A combined analysis of their results produces an overall consistent picture for the energy dependence of the cross section, while an inflation of the quoted uncertainties is needed to accommodate the observed discrepancy in the absolute scale of the different data sets. The origin of this discrepancy needs to be understood for a reliable estimate of the astrophysical rate of Be(p7,γ)8B and its uncertainty. In addition, there is a question about possible common systematic effects, considering that all measurements performed so far share the same experimental approach, i.e. an intense proton beam impinging on a Be7 radioactive target. A direct measurement using a radioactive Be7 ion beam on a pure hydrogen gas target has been since long envisioned as a way to improve the situation. First attempts showed the feasibility of an experiment based on the use of a recoil mass separator to collect reaction products with high efficiency, but failed to reach a useful statistical significance because of the low beam intensity. Here we present the results obtained using the intense Be7 beam available at the Tandem Accelerator Laboratory at CIRCE, University of Campania, Italy coupled to the recoil mass separator ERNA in the energy range Ecm=367 to 812 keV. Our results are compatible only with a part of previous measurements, in particular those indicating a low value of the astrophysical S-factor at zero energy S17, thus exacerbating the discrepancy between existing measurements. The analysis of our data together with the results of previous data provides an estimate S17(0)=20.0±0.8 eV⋅b, where systematic uncertainties are inflated to obtain a statistically compatible data set.

Published
2021

35. CLADAG 2019 Special Issue: Selected Papers on Classification and Data Analysis (editoriale)

Author

Greselin F., Murphy T. B., Porzio G. C., Vistocco D., Greselin, F., Murphy, T. B., Porzio, G. C., and Vistocco, D.

Abstract

This special issue of Statistical Analysis and Data Mining collects papers presented at the 12-th Scientific Meeting of the Classification and Data Analysis Group (CLADAG) of the Italian Statistical Society (SIS), held in Cassino, Italy, September 11 – 13, 2019. The CLADAG group, founded in 1997, promotes advanced methodological research in multivariate statistics with a special vocation in Data Analysis and Classification. CLADAG is a member of the International Federation of Classification Societies (IFCS). It organizes a biennial international scientific meeting, schools related to classification and data analysis, publishes a newsletter, and cooperates with other member societies of the IFCS to the organization of their conferences. Founded in 1985, the IFCS is a federation of national, regional, and linguistically-based classification societies aimed at promoting classification research. Previous CLADAG meetings were held in Pescara (1997), Roma (1999), Palermo (2001), Bologna (2003), Parma (2005), Macerata (2007), Catania (2009), Pavia (2011), Modena and Reggio Emilia (2013), Cagliari (2015), and Milano (2017). Best papers from the conference have been submitted to this special issue, and five of them have been selected for publication, following a blind peer-review process. The manuscripts deal with different data analysis issues: mixture of distributions, compositional data analysis, Markov chain for web usability, survival analysis, and applications to high-throughput, eye-tracking, and insurance transaction data. The paper by S.X. Lee et al. proposes a parallelization strategy of the Expectation-Maximization (EM) algorithm, with a special focus on the estimation of finite mixtures of flexible distribution such as the canonical fundamental skew t distribution (CFUST). The parallel implementation of the EM-algorithm is suitable for single-threaded and multi-threaded processors as well as for single machine and multiple-node systems. The EM algorithm is also discussed in the paper of L. Scrucca. Here, a fast and efficient Modal EM algorithm for identifying the modes of a density estimated through a finite mixture of Gaussian distributions with parsimonious component covariance structures is provided. The proposed approach is based on an iterative procedure aimed at identifying the local maxima, exploiting features of the underlying Gaussian mixture model. Motivated by applications in high-throughput compositional data analysis, the paper by N. Štefelová et al. proposes a data-driven weighting strategy to enhance marker identification through PLS regression with compositional predictors. The weighting strategy draws on the correlation structure between response variable and pairwise log-ratios. Its practical relevance is illustrated through an analysis of metabolite signals associated with the emission of greenhouse gases from cattle. The paper by G. Zammarchi et al. exploits Markov chain to analyse web usability of a University website using eye tracking methodology. With the aim of improving its usability, the paper compares performances of high school and University students in terms of time to completion, number of fixations and difficulty ratio across ten different tasks. Data from a commercial insurance company in the Czech Republic are instead exploited by D. Zapletal to compare the efficacy of some survival analysis models within an insurance transaction framework. The ability to identify relevant explanatory variables through the Cox proportional hazard model and some competing risk models (i.e., the cause-specific and the sub-distribution hazard models) is assessed on a large data set consisting of more than 200 thousand individuals. In brief, this special issue is in line with the CLADAG goal of supporting the interchange of ideas in Classification and Data Analysis. We strongly believe it well represents the scientific characteristics of the CLADAG community, and we invite all readers to join the next CLADAG conference, which will be in Florence, September 11 to 13, 2021.

Published
2021

36. Determination of the Be(p7,γ)8B cross section at astrophysical energies using a radioactive 7Be ion beam

Author

Buompane, R., primary, Di Leva, A., additional, Gialanella, L., additional, D'Onofrio, A., additional, De Cesare, M., additional, Duarte, J.G., additional, Fülöp, Z., additional, Gasques, L.R., additional, Gyürky, Gy., additional, Morales-Gallegos, L., additional, Marzaioli, F., additional, Palumbo, G., additional, Porzio, G., additional, Rapagnani, D., additional, Roca, V., additional, Rogalla, D., additional, Romoli, M., additional, Santonastaso, C., additional, and Schürmann, D., additional

Published
2022
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38. Corrigendum to ‘The lung immuno-oncology prognostic score (LIPS-3): a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer’: [ESMO Open Volume 6, Issue 2, April 2021, 100078]

Author

Banna, G.L., Cortellini, A., Cortinovis, D.L., Tiseo, M., Aerts, J.G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., and Addeo, A.

Published
2021
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39. Corrigendum to 'The lung immuno-oncology prognostic score (LIPS-3): a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer': [ESMO Open Volume 6, Issue 2, April 2021, 100078]

Author

Banna, GL, Cortellini, A, Cortinovis, DL, Tiseo, M, Aerts, JGJV, Barbieri, F, Giusti, R, Bria, E, Grossi, F, Pizzutilo, P, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Marco, R, Cantini, L, Nigro, O, D'Argento, E, Buti, S, Minuti, G, Landi, L, Guaitoli, G, Lo Russo, G, De Toma, A, Donisi, C, Friedlaender, A, De Giglio, A, Metro, G, Porzio, G, Ficorella, C, and Addeo, A

Abstract

ispartof: ESMO Open vol:6 issue:3 pages:100137- ispartof: location:England status: published

Published
2021

40. 966P Diabetes therapy burden as proxy of impairment of immune checkpoint inhibitors efficacy

Author

Cortellini, A., primary, Mallardo, D., additional, Cleary, S., additional, Bersanelli, M., additional, Santini, D., additional, Tucci, M.G., additional, Russo, A., additional, Rastelli, F., additional, Filetti, M., additional, Gelibter, A.J., additional, Marconcini, R., additional, Chiari, R., additional, Grossi, F., additional, De Tursi, M., additional, Queirolo, P., additional, Zoratto, F., additional, Tanda, E.T., additional, Porzio, G., additional, Ascierto, P.A., additional, and Pinato, D.J., additional

Published
2021
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42. Post-Induction Management in Patients With Left-Sided RAS and BRAF Wild-Type Metastatic Colorectal Cancer Treated With First-Line Anti-EGFR-Based Doublet Regimens: A Multicentre Study

Author

Parisi A, Cortellini A, Venditti O, Filippi R, Salvatore L, Tortora G, Ghidini M, Nigro O, Gelsomino F, Zurlo I, Fulgenzi C, Lombardi P, Keraenen S, Depetris I, Giampieri R, Morelli C, Di Marino P, Di Pietro F, Zanaletti N, Vitale P, Garajova I, Spinelli G, Zoratto F, Roberto M, Petrillo A, Aimar G, Patruno L, D'Orazio C, Ficorella C, Ferri C, and Porzio G

Subjects
FOLFIRI, FOLFOX, observation, MCRC, cetuximab, panitumumab, maintenance, de-escalation
Abstract

Background Few data regarding post-induction management following first-line anti-epidermal growth factor receptor (EGFR)-based doublet regimens in patients with left-sided RAS/BRAF wild-type metastatic colorectal cancer (mCRC) are available. Methods This multicenter, retrospective study aimed at evaluating clinicians' attitude, and the safety and effectiveness of post-induction strategies in consecutive patients affected by left-sided RAS/BRAF wild-type mCRC treated with doublet chemotherapy plus anti-EGFR as first-line regimen, who did not experience disease progression within 6 months from induction initiation, at 21 Italian and 1 Spanish Institutions. The measured clinical outcomes were: progression-free survival (PFS), overall survival (OS), adverse events, and objective response rate (ORR). Results At the data cutoff, among 686 consecutive patients with left-sided RAS/BRAF wild-type mCRC treated with doublet plus anti-EGFR as first-line regimen from March 2012 to October 2020, 355 eligible patients have been included in the present analysis. Among these, 118 (33.2%), 66 (18.6%), and 11 (3.1%) received a maintenance with 5-fluorouracil/leucovorin (5FU/LV)+anti-EGFR, anti-EGFR, and 5FU/LV, respectively, while 160 (45.1%) patients continued induction treatment (non-maintenance) until disease progression, unacceptable toxicity, patient decision, or completion of planned treatment. The median period of follow-up for the overall population was 33.7 months (95%CI = 28.9-35.6). The median PFS values of the 5FU/LV+anti-EGFR, anti-EGFR, 5FU/LV, and non-maintenance cohorts were 16.0 (95%CI = 14.3-17.7, 86 events), 13.0 (95%CI = 11.4-14.5, 56 events), 14.0 (95%CI = 8.1-20.0, 8 events), and 10.1 months (95%CI = 9.0-11.2, 136 events), respectively (p < 0.001). The median OS values were 39.6 (95%CI = 31.5-47.7, 43 events), 36.1 (95%CI = 31.6-40.7, 36 events), 39.5 (95%CI = 28.2-50.8, 4 events), and 25.1 months (95%CI = 22.6-27.6, 99 events), respectively (p < 0.001). After adjusting for key covariates, a statistically significant improvement in PFS in favor of 5FU/LV+anti-EGFR (HR = 0.59, 95%CI = 0.44-0.77, p < 0.001) and anti-EGFR (HR = 0.71, 95%CI = 0.51-0.98, p = 0.039) compared to the non-maintenance cohort was found. Compared to the non-maintenance cohort, OS was improved by 5FU/LV+anti-EGFR (HR = 0.55, 95%CI = 0.38-0.81, p = 0.002) and, with marginal significance, by anti-EGFR (HR = 0.67, 95%CI = 0.51-0.98, p = 0.051). No difference was found in ORR. Any grade non-hematological and hematological events were generally higher in the non-maintenance compared to the maintenance cohorts. Conclusion Among the treatment strategies following an anti-EGFR-based doublet first-line induction regimen in patients affected by left-sided RAS/BRAF wild-type mCRC treated in a "real-life" setting, 5FU/LV+anti-EGFR resulted the most adopted, effective, and relatively safe regimen.

Published
2021

43. Smoking status during first-line immunotherapy and chemotherapy in NSCLC patients: A case–control matched analysis from a large multicenter study

Author

Cortellini, A. (Alessio), De Giglio, A. (Andrea), Cannita, K. (Katia), Cortinovis, D.L. (Diego L.), Cornelissen, R. (Robin), Baldesarri, C. (Cinzia), Giusti, R. (Raffaele), D'Argento, E. (Ettore), Grossi, F. (Francesco), Santoni, M. (Matteo), Catino, A. (Annamaria), Berardi, R. (Rossana), Sforza, V. (Vincenzo), Rossi, G. (Giovanni), Antonuzzo, L. (Lorenzo), Di Noia, V. (Vincenzo), Signorelli, D. (Diego), Gelibter, A. (Alain), Occhipinti, M.A. (Mario Alberto), Follador, A. (Alessandro), Rastelli, F. (Francesca), Chiari, R. (Rita), Gravara, L.D. (Luigi Della), Inno, A. (Alessandro), De Tursi, M. (Michele), Di Marino, P. (Pietro), Mansueto, G. (Giovanni), Zoratto, F. (Federica), Filetti, M. (Marco), Montrone, M. (Michele), Citarella, F. (Fabrizio), Pensieri, M.V. (Maria Vittoria), Russano, M. (Marco), Cantini, L. (Luca), Nigro, O. (Olga), Leonetti, A. (Alessandro), Bordi, P. (Paola), Minuti, G. (Gabriele), Landi, L. (Lorenza), De Toma, A. (Alessandro), Donisi, C. (Clelia), Ricciardi, S. (Serena), Migliorino, M.R. (Maria Rita), Napoli, V.M. (Valerio Maria), Leone, G. (Gianmarco), Metro, G. (Giulio), Banna, G.L. (Giuseppe L.), Friedlaender, A. (Alex), Addeo, A. (Alfredo), Ficorella, C. (Corrado), Porzio, G. (Giampiero), Cortellini, A. (Alessio), De Giglio, A. (Andrea), Cannita, K. (Katia), Cortinovis, D.L. (Diego L.), Cornelissen, R. (Robin), Baldesarri, C. (Cinzia), Giusti, R. (Raffaele), D'Argento, E. (Ettore), Grossi, F. (Francesco), Santoni, M. (Matteo), Catino, A. (Annamaria), Berardi, R. (Rossana), Sforza, V. (Vincenzo), Rossi, G. (Giovanni), Antonuzzo, L. (Lorenzo), Di Noia, V. (Vincenzo), Signorelli, D. (Diego), Gelibter, A. (Alain), Occhipinti, M.A. (Mario Alberto), Follador, A. (Alessandro), Rastelli, F. (Francesca), Chiari, R. (Rita), Gravara, L.D. (Luigi Della), Inno, A. (Alessandro), De Tursi, M. (Michele), Di Marino, P. (Pietro), Mansueto, G. (Giovanni), Zoratto, F. (Federica), Filetti, M. (Marco), Montrone, M. (Michele), Citarella, F. (Fabrizio), Pensieri, M.V. (Maria Vittoria), Russano, M. (Marco), Cantini, L. (Luca), Nigro, O. (Olga), Leonetti, A. (Alessandro), Bordi, P. (Paola), Minuti, G. (Gabriele), Landi, L. (Lorenza), De Toma, A. (Alessandro), Donisi, C. (Clelia), Ricciardi, S. (Serena), Migliorino, M.R. (Maria Rita), Napoli, V.M. (Valerio Maria), Leone, G. (Gianmarco), Metro, G. (Giulio), Banna, G.L. (Giuseppe L.), Friedlaender, A. (Alex), Addeo, A. (Alfredo), Ficorella, C. (Corrado), and Porzio, G. (Giampiero)

Abstract

Background: Improved outcome in tobacco smoking patients with non-small cell lung cancer (NSCLC) following immunotherapy has previously been reported. However, little is known regarding this association during first-line immunotherapy in patients with high PD-L1 expression. In this study we compared clinical outcomes according to the smoking status of two large multicenter cohorts. Methods: We compared clinical outcomes according to the smoking status (never smokers vs. current/former smokers) of two retrospective multicenter cohorts of metastatic NSCLC patients, treated with first-line pembrolizumab and platinum-based chemotherapy. Results: A total of 962 NSCLC patients with PD-L1 expression ≥50% who received first-line pembrolizumab and 462 NSCLC patients who received first-line platinum-based chemotherapy were included in the study. Never smokers were confirmed to have a significantly higher risk of disease progression (hazard ratio [HR] = 1.49 [95% CI: 1.15–1.92], p = 0.0022) and death (HR = 1.38 [95% CI: 1.02–1.87], p = 0.0348) within the pembrolizumab cohort. On the contrary, a nonsignificant trend towards a reduced risk of disease progression (HR = 0.74 [95% CI: 0.52–1.05], p = 0.1003) and death (HR = 0.67 [95% CI: 0.45–1.01], p = 0.0593) were reported for never smokers within the chemotherapy cohort. After a random case–control matching, 424 patients from both cohorts were paired. Within the matched pembrolizumab cohort, never smokers had a significantly shorter progression-free survival (PFS) (HR = 1.68 [95% CI: 1.17–2.40], p = 0.0045) and a nonsignificant trend towards a shortened overall survival (OS) (HR = 1.32 [95% CI: 0.84–2.07], p = 0.2205). On the contrary, never smokers had a significantly longer PFS (HR = 0.68 [95% CI: 0.49–0.95], p = 0.0255) and OS (HR = 0.66 [95% CI: 0.45–0.97], p = 0,0356) compared to current/former smoker patients within the matched chemotherapy cohort. On pooled multivariable analysis, the interaction term between smoking stat

Published
2021
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44. Corrigendum to 'The lung immuno-oncology prognostic score (LIPS-3):a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer': [ESMO Open Volume 6, Issue 2, April 2021, 100078

Author

Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., Addeo, A., Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., and Addeo, A.

Published
2021

45. Measurement error models on spatial network lattices: car crashes in Leeds

Author

C. Porzio, G, Rampichini, C, Bocci, C, Gilardi, A, Borgoni, R, Presicce, L, Mateu, J, Gilardi, A., Borgoni, R., Presicce, L., Mateu, J., C. Porzio, G, Rampichini, C, Bocci, C, Gilardi, A, Borgoni, R, Presicce, L, Mateu, J, Gilardi, A., Borgoni, R., Presicce, L., and Mateu, J.

Abstract

Road casualties represent the leading cause of death among young people worldwide, especially in poor and developing countries. This paper introduces a Bayesian hierarchical model to analyse car accidents on a network lattice that takes into account measurement error in spatial covariates. We exemplified the proposed approach analysing all car crashes that occurred in the road network of Leeds (UK) from 2011 to 2019. Our results show that omitting measurement error considerably worsens the fit of the model and attenuates the effects of spatial covariates.

Published
2021

47. Group-dependent finite mixture model

Author

Porzio G. C., Rampichini C., Bocci C., Costa Fontichiari, P., Giuliani, M., Argiento, Raffaele, Paci, Lucia, Argiento R. (ORCID:0000-0001-8416-1642), Paci L. (ORCID:0000-0001-7403-2054), Porzio G. C., Rampichini C., Bocci C., Costa Fontichiari, P., Giuliani, M., Argiento, Raffaele, Paci, Lucia, Argiento R. (ORCID:0000-0001-8416-1642), and Paci L. (ORCID:0000-0001-7403-2054)

Abstract

We present a Bayesian nonparametric group-dependent mixture model for clustering. This is achieved by building a hierarchical structure, where the discreteness of the shared base measure is exploited to cluster the data, between and within groups. We study the properties of the group-dependent clustering structure based on the latent parameters of the model. Furthermore, we obtain the joint distribution of the clustering induced by the hierarchical mixture model and define the complete posterior characterization of interest. We construct a Gibbs sampler to perform Bayesian inference and measure performances on simulated and a real data.

Published
2021

48. The lung immuno-oncology prognostic score (LIPS-3):a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer

Author

Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., Addeo, A., Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., and Addeo, A.

Abstract

Background: To stratify the prognosis of patients with programmed cell death-ligand 1 (PD-L1) ≥ 50% advanced non-small-cell lung cancer (aNSCLC) treated with first-line immunotherapy. Methods: Baseline clinical prognostic factors, the neutrophil-to-lymphocyte ratio (NLR), PD-L1 tumour cell expression level, lactate dehydrogenase (LDH) and their combination were investigated by a retrospective analysis of 784 patients divided between statistically powered training (n = 201) and validation (n = 583) cohorts. Cut-offs were explored by receiver operating characteristic (ROC) curves and a risk model built with validated independent factors by multivariate analysis. Results: NLR < 4 was a significant prognostic factor in both cohorts (P < 0.001). It represented 53% of patients in the validation cohort, with 1-year overall survival (OS) of 76.6% versus 44.8% with NLR > 4, in the validation series. The addition of PD-L1 ≥ 80% (21% of patients) or LDH < 252 U/l (25%) to NLR < 4 did not result in better 1-year OS (of 72.6% and 74.1%, respectively, in the validation cohort). Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 [P < 0.001, hazard ratio (HR) 2.04], pretreatment steroids (P < 0.001, HR 1.67) and NLR < 4 (P < 0.001, HR 2.29) resulted in independent prognostic factors. A risk model with these three factors, namely, the lung immuno-oncology prognostic score (LIPS)-3, accurately stratified three OS risk-validated categories of patients: favourable (0 risk factors, 40%, 1-year OS of 78.2% in the whole series), intermediate (1 or 2 risk factors, 54%, 1-year OS 53.8%) and poor (>2 risk factors, 5%, 1-year OS 10.7%) prognosis. Conclusions: We advocate the use of LIPS-3 as an easy-to-assess and inexpensive adjuvant prognostic tool for patients with PD-L1 ≥ 50% aNSCLC.

Published
2021

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